Last Updated on January 3, 2024 by The Health Master
Windsor, New Jersey, Eugia US LLC (formerly AuroMedics Pharma LLC) has initiated a voluntary recall of lot number AC22006 of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single-dose vials to the consumer level in the U.S. market.
This product was recalled due to a product complaint for the presence of dark red, brown, and black particulate inside the vial.
Risk Statement: The administration of an intravenous product containing particulates has the potential to result in inflammation, allergic reactions, or circulatory system complications that could be life-threatening.
To date, Eugia US LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed for this lot.
AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), contains acyclovir, a synthetic nucleoside analog, active against herpes viruses.
Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1) and HSV-2) in immunocompromised patients and initial clinical episodes of herpes genitalis in immunocompetent patients.
It is packaged in a glass vial labeled with NDC 55150-154-10. The lot being recalled is AC22006 with an expiration date of 08/2023.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
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